Syringe

ABSTRACT

A syringe formed of inner and outer tubular members with the inner member adapted to be telescoped within the outer member and sealed therefrom by a sealing assembly comprising a disc member having at least one opening therethrough communicating with the inner tubular member and a flexible seal having a disc portion having openings therethrough, with the openings in the disc member being laterally offset from the opening in the disc portion, while the outer member is formed with a rupturable seal having an injection needle in alignment therewith for rupture in use with the inner tubular member adapted to contain a liquid carrier and the outer tubular member adapted to carry a solid medicant to be taken up with the carrier for injection whereby the materials are freshly mixed immediately prior to injection.

United States Patent [15] 3,678,931 [451 July 25,1972

Cohen SYRINGE [72] Inventor: Milton J. Cohen, 7111 Connecticut Ave.,

Chevy Chase, Md. 20015 [22] Filed: June 9, 1970 [21] Appl. No.2 44,742

[521 (LS. CL. ....128/220, 128/218 M [51] Int. Cl. ..A61m 5/00 [58]Field ofSearch ..128/2l8 M, 220,218 P, 2.8 PA, 128/234 [56] ReferencesCited UNITED STATES PATENTS 3,342,180 9/1967 Sandage et a1. ..128/2l8 M3,557,787 l/l97l Cohen ..128/218 M 3,052,239 9/1962 Silver et al........128/218 M 2,607,344 8/1952 Brown ..l28/218 M 2,591,706 4/1952Lockhart ..l28/218 M 3,330,282 2/1967 Visser et al.. .128/218 M X2,675,804 4/1954 Krug ..l28/2l8 M 3,511,239 5/1970 Tuschhoff ..128/218MPrimary Examiner-Louis G. Mancene Assistant Examiner-D. L. WeinholdAttorney-McDougall, Hersh & Scott [57] ABSTRACT A syringe formed ofinner and outer tubular members with the inner member adapted to betelescoped within the outer member and sealed therefrom by a sealingassembly comprising a disc member having at least one openingtherethrough communicating with the inner tubular member and a flexibleseal having a disc portion having openings therethrough, with theopenings in the disc member being laterally offset from the opening inthe disc portion, while the outer member is formed with a rupturableseal having an injection needle in alignment therewith for rupture inuse with the inner tubular member adapted to contain a liquid carrierand the outer tubular member adapted to carry a solid medicant to betaken up with the carrier for injection whereby the materials arefreshly mixed immediately prior to injection.

Patented July 25, 1972 2 Shuts-Sheet l 75 FIG. 4

INVENTOR afys' Patented July 25, 1972 2 Shoots-Sheet 2 FIG. 5

FIG. 7

mr/f/// SYRINGE This invention relates to a device for theadministration of parenteral solutions and more particularly to ahypodermic syringe adapted to contain dry solids separate and apart fromthe dissolving or carrier liquids until, immediately prior toadministration, the liquid is caused to flow into the compartmentcontaining the solids for injection of the formed mixture.

To the present, it has been the practice to make use of stock solutionshoused within a container of relatively large capacity, from whichincrements can be removed, as desired, for administration by a suitablesyringe. This procedure is deemed to be unsatisfactory because most suchsolutions are of insufficient stability to militate against changebefore the stock solu tion has been used up. With a solution of shortshelf life", its utility may become dissipated before the solution hasbeen completely utilized.

The most effective means for maintaining the shelf life" over extendedperiods of time is to maintain complete separation between the liquidcarrier and the solids to be incorporated therein, until immediatelyprior to use. Maintenance of solid-liquid separation until time of usepresents other problems with respect to ejecting and administering thesolution containing the necessary concentration of ingredients and underthe most sanitary conditions. The usual practice is to introduce thesolids into the liquid for solution in a suitable container from whichthe solution can be withdrawn into a syringe for injection. Thisprocedure requires the use of at least three separate containers andmaintenance under sterile conditions as well as accurate measurement ofthe ingredients.

In copending application Ser. No. 632,622, filed May 28, I968 andentitled Disposable Syringe", description is made of a syringe in whichaccurately measured amounts of solid medicants and liquid carrier can bemaintained in a completely separated state, and can be admixed togetherand injected, while the contents of the syringe are in a sealed andsanitary condition.

The present invention relates to a further improved syringe of the typedescribed in which use is made of a further simplified and improvedclosure member between the liquid-containing and solid-containingcompartments.

It is an object of the present invention to provide a new and improvedsyringe which houses both liquids and solids in separately sealedcompartments whereby admixture of the liquids and solids can be effectedcompletely within the confines of the syringe in a simple and efficientmanner to provide a freshly prepared medicant solution which can beinjected in the manner desired for use.

This and other objects and advantages of the invention will appearhereinafter, and, for purposes of illustration, but not of limitation,an embodiment of the invention is shown in the accompanying drawings inwhich:

FIG. 1 is a sectional elevational view of a syringe embodying thefeatures of the invention, illustrating the position of the elementsprior to use;

FIG. 2 is a plane view of a flexible disc member forming part of theclosure assembly of the present invention;

FIG, 3 is a plane view of the flexible seal of the closure assembly ofthe present invention;

FIG. 4 is a sectional elevational view of the syringe shown in FIG. Iwith the syringe partially actuated to efiect displacement of the liquidcontents from the liquid-containing chamber to the colids-containingchamber for admixture; and,

FIG. 5 is a sectional elevational view of the syringe shown in FIGS. 1and 2 with the syringe in fully actuated position to ef fectdisplacement of the freshly prepared medicant solution from the solidschamber for injection;

FIG. 6 is a sectional elevational view of an actuator which may also beused as a needle cover;

FIG. 7 is a sectional elevational view of the syringe of FIG. 1 havingan alternative needle assembly.

The concepts of the present invention reside in a syringe comprisinginner and outer tubular members with the inner tubular member adapted tobe telescoped within the outer tubular member, a hypodermic needleassembly including a rupturable closure sealing the forward end of theouter tubular member in which the closure is adapted to be ruptured inresponse to displacement of a needle and a flexible closure assemblysealing the forward end of the inner tubular member including a discmember having one or more openings therethrough communicating with theinterior of the inner tubular member and a flexible seal having asubstantially flat surface portion in face-to-face sealing contact withthe disc member.

The surface portion of the flexible seal is also provided with at leastone opening therethrough, which is offset from the opening or openingsin the disc member to prevent the passage of a liquid contained in achamber defined by the inner tubular member. When the interior of theinner tubular member is subjected to an internal pressure duringdisplacement of the liquid from the chamber defined thereby, the liquidpasses through the openings in the disc to thereby flex the surfaceportion of the flexible seal, forming a space between the flexible discand the flexible seal. Thus, the liquid contained in the chamber definedby the inner tubular member can pass through the openings in theflexible disc member and surface portionof the flexible seal, andthrough the opening or openings in the flexible seal into thesolids-containing chamber defined by the outer tubular member foradmixture with the solids to form a fresh medicant solution forinjection.

By the same token, an internal pressure in the chamber defined by theouter tubular member, such as that caused during injection, serves tourge the surface portion of the flexible seal toward sealing contactwith the disc to prevent flow of liquid through the flexible closureassembly in the reverse direction. In this way once admixture of theliquid with the solid has been made, it is no longer necessary tomaintain a pressure in the chamber defined by the inner tubular member,and injection of the freshly prepared solution can be effected bydisplacing the inner tubular member toward the outer tubular member.

Referring now to the drawings, there is shown in FIG. 1 a syringeembodying the features of the invention comprising an outer casing 10 inthe shape of a tubular member formed of glass, plastic or the likehaving a continuous bore 12 extending therethrough from an open rearwardend portion 14 of smaller cross section at the forward end.

The forward end of tubular member 10 is sealed by means of a diaphram ordisc member 18 held in place in a sealing relationship across the openneck 16 of tubular member 10 by means of a cap 20 forming part of theneedle assembly which is crimped about the outer neck portion of thetubular member, while the inner portions 22 of cap 20 overlap the outeredge of the disc member 18 overlying annular flange 24 to tubular member10. The rearward end of tubular member 10 is formed with an outwardlyextending flange 26 which serves as a finger grip.

The needle assembly comprises the cap 20 which is crimped about annularflange 24, and a hollow needle 28. Needle 28 is carried by a bushing 30which is slidably mounted in a recess 32 formed by the annular wall 34of cap 20, and is held in place by inwardly extending flange 36 locatedon the annular wall 34 of cap 20. Bushing 30 is provided at its rearwardend with an outwardly extending flange 38 having a cross section greaterthan the cross section of flange 36 to prevent the bushing 30 and needle28 from being released from recess 32. In addition, bushing 30 andneedle 28 are spring biased against flange 36 by spring means 40 tomaintain sharpened portion 42 of needle 28 which extends rearwardly frombushing 30 adjacent to disc member 18.

A second tubular member 44 formed of glass, plastic or the like materialis dimensioned to have an outer wall-to-wall dimension which is lessthan the inner wall-to-wall dimension of tubular member 10 whereby thesecond tubular member 44 is adapted to be telescoped through the outertubular member 10. The second or inner tubular member 44 is similarlyformed with a passage 46 extending from an open rearward end 48 througha neck portion 50 at the forward end having a smaller cross section.

The forward neck end portion of the inner tubular member 44 is fittedwith flexible sealing member 52 including an outer ribbed portion 54fitted in a gripping relationship about the neck of inner tubular member44 and extending laterally beyond the vwall of the inner tubular member44 for a distance to efiect sealing engagement with the inner wall ofouter tubular member whereby inner tubular member is capable offunctioning as a piston which is moveable axially relative to the outertubular member 10 to thereby provide a piston and cylinder arrangementbetween the inner and outer tubular members 44 and 10, respectively.

Flexible sealing member 52 is illustrated as having a gripping member 56which extends inwardly to grip annular flange 58 formed at forward endof inner tubular member 44 to effect the gripping relation describedabove. Flexible sealing member 52 is also provided with a substantialflat or disc portion 60 having one or more passage means 62 extendingtherethrough.

Disc portion 60 of flexible sealing member 52 overlays a disc member 64which in turn overlays annular flange 58 formed at the forward end ofinner tubular member 44. Thus, disc member 64 is held in place inabutting relation with flange 58 by means of flexible sealing member 52.Disc member 64, which need not be, but preferably is formed of aflexible material such as rubber, is provided with a plurality ofopenings 66 therethrough which communicate with the chamber defined bytubular member 44, but which are offset laterally from the opening oropenings 62 defined by the disc portion 60. Thus, when there is nointernal pressure in the chamber defined by tubular member 44, theopenings 66 in disc member 64 are sealed by the disc portion 60 offlexible sealing member 52.

The disc member 64 and flexible sealing member 52 are best illustratedin FIGS. 2 and 3, respectively. As shown in FIG. 2, the openings 66extending through disc member 64 are spaced about the center of the discmember 64 but are spaced outwardly from axial alignment with passage 46.As shown in FIG. 3, the opening 62 in discportion 60 is located at thecenter thereof. Disc member 64 and disc portion 60 are concentric, andthus opening 62 in disc portion 60 overlays the center of disc member'64 in sealing relation therewith. Thus, disc portion 60 of flexiblesealing member 52 is flexed for displacement from sealing relation withdisc member 64 in responseto an internal pressure within the chamberdefined by tubular member 44. However, as will be understood by thoseskilled in the art, openings 62 and 66 can have a variety of otheroffset positions.

The rearward end portion of the inner tubular member 44 is formed withan outwardly extending flanged portion 68 which similarly serves as afinger grip, as will be hereinafter described. The rearward end ofpassage 46 is sealed with an elastomeric plug 70 mounted for axialdisplacement through passage 46 as a piston within the cylinder definedby inner tubular member 44. Means, such as a threaded stud 72, isprovided on the rearward end of the plug 70 for connection of anactuator 74 for displacement of the piston 70 relative to the cylinder.

In the drawing, the actuator 74 is in the form of a third elongatetubular member dimensioned to have a cross section less than the crosssection of passage 46 through inner tubular member 44 and formed at oneend with an internally threaded engagement onto threaded stud 72. Therearward end of actuator 74 is formed with an outwardly extending flangeportion 78 for use as a finger grip.

In the modification shown in FIG. 6, actuator 74' is capable of use as aneedle cover to protect needle 28 when not in a position ready for use,and which can be removed from the bushing 30 to expose the needle andfor attachment to the stud 72 for operation of the device, when inposition for use. Thus, this element serves a dual function of a needleprotector during non-use and of an actuator in use.

By way of further modification, use can also be made of a needleassembly of the type described in copending application Ser. No. 732,622as shown in FIG. 7 of the drawings.-As illustrated in this figure, theouter tubular member 10 is sealed at neck 16' by means of a diaphragm l8overlaying flange 24. Diaphragm 18' is maintained in a sealing positionwith flange 24' by means of a cap 78 which is crimped about the outerneck portion of tubular member 10' while the inner portion 80 of the cap78 overlays diaphragm 18'.

A hub member 82 has a skirt portion 84 which is crimped about the skirtportion of the cap for securing the hub onto the neck end portion oftubular member 10 The hub is also formed with an intermediatecollapsible portion 86 extending forwardly in axial alignment with theforward end of tubular member 10' with a hub 88 on the forward endthrough which a hollow needle 28' extends with a sharpened end portion42 of needle 28' projecting into the interior of hub member 82 for adistance less than the spaced relationship between the hub end 88 andthe diaphragm 18', when in position prior to use, to thereby positionthe rearward end 42' of the needle 28' immediately in advance of thecenter of the diaphragm 18.

In the assembled device as illustrated in FIG. 1, a fluid 90 is housedwithin the inner tubular member 44, while a solid medicant 92 is housedwithin tubular member 10. Both chambers are sealed, and therefore theloaded device can be stored and/or shipped for extended periods of timewithout deteri oration of the contents and without exposure of thecontents to non-sanitary conditions.

In use, the device can be held with two fingers under flange 68 of theinner tubular member 44, and the actuator 74 is pressed by the thumb toeffect displacement of the plug 70 through cylindrical passage 46.Thisin turn subjects the liquid 90 to pressure. The liquid passes throughopenings 66 in disc member 64 whereby the pressure transfers to theresilient disc portion 60 of flexible sealing member 52 to cause flexurein disc portion 60 to thereby form a small space 94 defined between discmember 64 and flexed disc portion 60. Thus, liquid contained withintubular member 44 is caused to be displaced under pressure throughopenings 66 in disc member 64, into space 94 and through disc portion 60through opening 62 into the outer tubular member 10 in which the liquid90 is admixed with the solid 92. This intermediate position isillustrated in FIG. 4 of the drawing. The liquid carries the medicantinto solution or suspension, with shaking when necessary, to provide afreshly prepared fluid system ready for administration by injection.

Administration of the freshly prepared fluid system can be made withouttransferring the fluid from one device to another and without exposureby inserting the needle 28 into the-vessel or tissue. Thus, the outercasing is grasped with one hand with the needle fingers between theflange 26, and the needle is inserted. In the embodiment shown in FIG.1, removal of the needle cover releases the spring biased needle andbushing and causes the bushing 30 carrying needle 28 to be displacedrearwardly whereby the rearward end 42 of needle 28 punctures thediaphragm 18 to bring the end of the needle into the chamber defined bytubular member 10 for direct communication with the freshly preparedfluid system.

In the embodiment shown in FIG. 7, insertion of the needle 28'compresses the hub member 86 to effect relative movement between needle78' and diaphragm 18' whereby the rearward end 42' of needle 28'ruptures diaphragm 18' for direct communication with the liquid system.

Thereafter, the thumb is pressed down on the actuator which, at the endof its travel in tubular member 44, causes displacement of the innertubular member for movementas a piston through the cylindrical passage12 to thereby forcibly displace the freshly prepared liquid system fromthe interior of tubular member 10 through the needle and into thetissue, as shown in. FIG. 5. Reverse flow of the liquid system due to afluid pressure within tubular member 10 back through openings 62 and 66is prevented by virtue of the fact that fluid pressure within tubularmember 10 urges disc portion 60 toward a sealing relation with discmember 64.

Upon administration of the freshly prepared solution, the entire devicecan be discarded.

It will be apparent from the foregoing that I have provided a simpledisposable syringe capable of operation with one hand in which liquidsand solids are maintained in separately sealed chambers and mixedimmediately prior to injection by a simple operation of the device.

It will be understood that changes may be made in the details ofconstruction, arrangement and operation without departing from thespirit of the invention, especially as defined in the following claims.

I claim:

1. In a syringe assembly including inner and outer tubular members withthe inner tubular member having an outer wallto-wall dimension less thanthe inner wall-to-wall dimension of the outer tubular member to enablethe inner tubular member to be telescoped within the outer tubularmember, a rupturable closure sealing the forward end of the outertubular member, a hypodermic needle, means supporting said needle topermit said needle to penetrate said rupturable closure in response toinsertion of said needle, a piston plug dimensioned to be slidablyreceived within the inner tubular member, and means to actuate thepiston plug axially relative to the inner tubular member, theimprovement comprising a flexible seal sealing the forward end of theinner tubular member, said seal comprising a piston ring portion on theforward end of the forward end of the inner tubular member in slidingengagement with the inner walls of the outer tubular member and aflexible disc portion having at least one opening therethroughcommunicating with the outer tubular member, and a disc member having atleast one opening therethrough communicating with the inner tubularmember, said disc portion overlaying said disc member in a sealingrelation on the forward end of the inner tubular member and the openingin said disc member being laterally offset from the opening in said discportion whereby said disc portion is flexed in response to an internalpressure within said inner tubular member and transmitted through theopening of the disc member to permit the flow of a fluid in the innertubular member through the openings in said disc member and said discportion to the outer tubular member.

2. A syringe as defined in claim 1 which includes a removable cover forthe needle.

3. A syringe as defined in claim 1 in which the inner tubular member isadapted to contain a liquid carrier and in which the outer tubularmember is adapted to contain a dry material to be taken up by the liquidcarrier when the latter is forced from the inner tubular member into theouter tubular member in response to movement of the piston plug axiallyin the inner tubular member.

4. A syringe as defined in claim 1 in which the piston ring portion onthe forward end of the inner tubular member comprises ring members ofrubber-like material in sealing engagement with the outer walls of theinner tubular member and extending into sealing engagement with theinner walls of the outer tubular member.

5. A syringe as defined in claim 1 wherein said disc member includes aplurality of openings in a position offset outwardly from axialalignment with the passage through the inner tubular member.

6. A syringe as defined in claim 1 wherein the opening through the discportion is positioned in axial alignment with the passage through theinner tubular member.

7. A syringe as defined in claim 1 which includes means on the rearwardend of the piston plug for attachment of an actuator and which includesan elongate actuator dimensioned to exceed the length of travel of thepiston plug through the inner tubular member.

8. A syringe as defined in claim 7 in which the actuator comprises anelongate rod dimensioned to be received in telescoping relation withinthe inner tubular member and with means for attachment of the actuatorto the iston plug.

9. A syringe as defined in claim I whic includes flanged membersextending radially outwardly from the rearward end portions of the innerand outer tubular members for use as finger grips.

10. A syringe as defined in claim 1 wherein said means supporting saidneedle includes a bushing and a cap member secured to the forward end ofthe outer tubular member and defining a recess, said bushing beingslidably positioned in said recess relative to the cap member wherebyinsertion of the needle displaces the needle to rupture said closure.

11. A syringe as defined in claim 1 wherein said means supporting saidneedle includes a collapsible hub member secured to the forward end ofthe outer tubular member, said hub member having a flexible portion topermit displacement of the needle to penetrate said closure in responseto insertion of said needle.

1. In a syringe assembly including inner and outer tubular members withthe inner tubular member having an outer wall-towall dimension less thanthe inner wall-to-wall dimension of the outer tubular member to enablethe inner tubular member to be telescoped within the outer tubularmember, a rupturable closure sealing the forward end of the outertubular member, a hypodermic needle, means supporting said needle topermit said needle to penetrate said rupturable closure in response toinsertion of said needle, a piston plug dimensioned to be slidablyreceived within the inner tubular member, and means to actuate thepiston plug axially relative to the inner tubular member, theimprovement comprising a flexible seal sealing the forward end of theinner tubular member, said seal comprising a piston ring portion on theforward end of the forward end of the inner tubular member in slidingengagement with the inner walls of the outer tubular member and aflexible disc portion having at least one opening therethroughcommunicating with tHe outer tubular member, and a disc member having atleast one opening therethrough communicating with the inner tubularmember, said disc portion overlaying said disc member in a sealingrelation on the forward end of the inner tubular member and the openingin said disc member being laterally offset from the opening in said discportion whereby said disc portion is flexed in response to an internalpressure within said inner tubular member and transmitted through theopening of the disc member to permit the flow of a fluid in the innertubular member through the openings in said disc member and said discportion to the outer tubular member.
 2. A syringe as defined in claim 1which includes a removable cover for the needle.
 3. A syringe as definedin claim 1 in which the inner tubular member is adapted to contain aliquid carrier and in which the outer tubular member is adapted tocontain a dry material to be taken up by the liquid carrier when thelatter is forced from the inner tubular member into the outer tubularmember in response to movement of the piston plug axially in the innertubular member.
 4. A syringe as defined in claim 1 in which the pistonring portion on the forward end of the inner tubular member comprisesring members of rubber-like material in sealing engagement with theouter walls of the inner tubular member and extending into sealingengagement with the inner walls of the outer tubular member.
 5. Asyringe as defined in claim 1 wherein said disc member includes aplurality of openings in a position offset outwardly from axialalignment with the passage through the inner tubular member.
 6. Asyringe as defined in claim 1 wherein the opening through the discportion is positioned in axial alignment with the passage through theinner tubular member.
 7. A syringe as defined in claim 1 which includesmeans on the rearward end of the piston plug for attachment of anactuator and which includes an elongate actuator dimensioned to exceedthe length of travel of the piston plug through the inner tubularmember.
 8. A syringe as defined in claim 7 in which the actuatorcomprises an elongate rod dimensioned to be received in telescopingrelation within the inner tubular member and with means for attachmentof the actuator to the piston plug.
 9. A syringe as defined in claim 1which includes flanged members extending radially outwardly from therearward end portions of the inner and outer tubular members for use asfinger grips.
 10. A syringe as defined in claim 1 wherein said meanssupporting said needle includes a bushing and a cap member secured tothe forward end of the outer tubular member and defining a recess, saidbushing being slidably positioned in said recess relative to the capmember whereby insertion of the needle displaces the needle to rupturesaid closure.
 11. A syringe as defined in claim 1 wherein said meanssupporting said needle includes a collapsible hub member secured to theforward end of the outer tubular member, said hub member having aflexible portion to permit displacement of the needle to penetrate saidclosure in response to insertion of said needle.